Hemofiltration systems and methods that maintain sterile extracorporeal processing conditions

• US 7,473,238 B2
• Filed: 08/27/2003
• Issued: 01/06/2009
• Est. Priority Date: 02/14/1997
• Status: Expired due to Term

• Current Assignee: Nxstage Medical Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Nxstage Medical Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Burbank, Jeffrey H., Brugger, James, Treu, Dennis
• Primary Examiner(s): Deak; Leslie R
• Application Number:
  US10/649,582
• Publication Number:
  US 20050045548A1
• Time in Patent Office: 1,959 Days
• Field of Search: 604/4.01, 604/5.01, 604/5.04, 604/6.09, 604/6.11, 604/7, 210/645, 210/646, 210/192.2, 210/200, 210/252, 210/257.2, 210/258, 210/416.1, 210/321.71, 210/433.1, 210/500.21, 422/44, 422/48
• US Class Current: 604/6.16
• CPC Class Codes: A61M 1/1639 linked by membranes
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3401 Cassettes therefor
• CPC Class Codes: A61M 1/341 by measuring the filtrate rate or volume
• CPC Class Codes: A61M 1/342 Adding solutions to the blood, e.g. substitution solutions for preventing coagulation A61M1/3672
• CPC Class Codes: A61M 1/3441 Substitution rate control as a function of the ultrafiltration rate
• CPC Class Codes: A61M 1/3444 in which the collected ultra-filtrate expels an equal volume of substitution fluid from a reservoir
• CPC Class Codes: A61M 1/3448 by mechanically linked pumps in both ultra-filtrate and substitution flow line
• CPC Class Codes: A61M 1/3458 having electrolytes not present in the dialysate
• CPC Class Codes: A61M 1/361 before treatment
• CPC Class Codes: A61M 1/3612 after treatment
• CPC Class Codes: A61M 1/362223 the interface being evacuated interfaces to enhance contact
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/36226 Constructional details of cassettes, e.g. specific details on material or shape
• CPC Class Codes: A61M 1/362262 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/3626 Gas bubble detectors
• CPC Class Codes: A61M 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 1/3646 Expelling the residual body fluid after use, e.g. back to the body
• CPC Class Codes: A61M 1/367 : Circuit parts not covered by the preceding subgroups of group A61M1/3621
• CPC Class Codes: A61M 2205/126 : with incorporated membrane filters
• CPC Class Codes: A61M 2205/128 : with incorporated valves
• CPC Class Codes: A61M 2205/15 : Detection of leaks
• CPC Class Codes: A61M 2205/3306 : Optical measuring means
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3375 : Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/35 : Communication
• CPC Class Codes: A61M 2205/3553 : remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3569 : sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/505 : Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/60 : with identification means
• CPC Class Codes: A61M 2205/6018 : providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6072 : Bar codes
• CPC Class Codes: A61M 39/0208 : Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276

Abstract

A disposable fluid circuit kit for extracorporeal blood treatment systems that supply replacement fluid to a patient is described. The circuit has a blood portion that carries blood and subjects it to some treatment, such as dialysis or hemofiltration. A portion carries filtrate or dialysate. A replacement fluid portion that carries fluid used to compensate for fluid loss is connectable to a supply of replacement fluid. a sterilizing filter in the replacement fluid portion sterilizes the replacement fluid before introduction into the patient acting as a guard against touch contamination of the connected replacement fluid container. Preferably, the filter has a pore size effective to eliminate pyrogens.

Claims

1. A disposable fluid circuit for use in extracorporeal blood treatment systems that supply replacement fluid to a patient, comprising:

a fluid circuit having a blood portion for carrying blood, a filtrate portion connectable across a porous membrane to said blood portion, and

a replacement fluid portion connectable to a supply of replacement fluid;

a sterilizing filter in said replacement fluid portion,

said sterilizing filter having a pore size effective to eliminate pyrogens from a fluid passing therethrough;

said replacement fluid portion having a plurality of connectors joined at a junction to flow through said sterilizing filter into a common inlet to the replacement fluid portion;

each of the plurality of connectors being connected to a respective one of multiple replacement fluid containers whose total content equals at least 8 liters of replacement fluid, each of the replacement fluid containers containing the same replacement fluid.

2. A circuit as in claim 1, further comprising a cartridge configured to support said sterilizing filter, and the blood, filtrate, and replacement fluid portions.

3. A circuit as in claim 1, wherein said plurality of connectors includes a plurality of bag spikes.

4. A circuit as in claim 1, wherein said sterilizing filter is in an in-line configuration such that all fluid passing through said replacement fluid portion is filtered thereby.

5. A circuit as in claim 1, further comprising respective pumping portions in said filtrate, blood, and replacement fluid portions each configured to engage with a respective pump actuator to move respective fluids through each of said plurality of connectors.

6. A circuit as in claim 5, further comprising a supporting cartridge tray configured to align said pumping portions in respective positions to allow them to engage with respective pump actuators.

7. A circuit as in claim 1, wherein one pumping portion is used for regulating flow between each of the plurality of connectors and the blood portion.

8. A disposable fluid circuit for use in extracorporeal blood treatment systems that supply replacement fluid to a patient, comprising:

a fluid circuit mounted in a cartridge;

said fluid circuit including a blood circuit portion connected to a filter, a replacement fluid circuit portion connected to said blood circuit portion, and a waste circuit portion connected to said filter;

the waste fluid circuit having multiple connectors joined to a common line that feeds replacement fluid to the blood circuit, the common line being a part of the replacement fluid portion;

each of the multiple connectors being connected to a respective one of multiple replacement fluid containers, each of which contains sterile replacement fluid effective to restore a normal electrolyte balance of human blood;

a sterilizing filter in said replacement fluid portion, said sterilizing filter having a pore size effective to eliminate pyrogens from a fluid passing therethrough;

said sterilizing filter being located in an in-line configuration such that all replacement fluid passing into said blood circuit portion must pass through a membrane thereof.

9. A circuit as in claim 8, further comprising:

a connector in said blood circuit portion for connecting a venous line of said blood circuit portion to a patient access;

said sterilizing filter being located between said source of replacement fluid and said blood circuit portion;

said replacement fluid circuit portion being connected to said venous line.

10. A circuit as in claim 8, wherein said cartridge includes a tray shaped element to support said blood, filtrate, and replacement fluid circuit portions.

11. A circuit as in claim 8, wherein said multiple connectors include a plurality of bag spikes.

12. A circuit as in claim 8, further comprising respective pumping portions in said filtrate, blood, and replacement fluid circuit portions that are configured to engage with respective pump actuators to move respective fluids therethrough.

13. A circuit as in claim 12, further comprising a supporting cartridge tray configured to align said pumping portions in respective positions to allow them to engage with pump actuators.

14. A disposable fluid circuit for use in extracorporeal blood treatment systems that supply replacement fluid to a patient, comprising:

a fluid circuit with a support;

said fluid circuit including arterial and venous blood lines connectable to a patient access at access ends thereof and connectable to a filter at filter ends thereof;

said fluid circuit including a replacement fluid line with an input end connectable to a replacement fluid supply and an output end connected to said venous blood line;

said replacement fluid line having an inline sterile filter between said input and output ends configured such that all fluid passing from said input end to said output end passes through a membrane effective to block pyrogens;

wherein said input end of said replacement fluid line has a branching connector with multiple ends for connection connected to multiple fluid sources of a same infusible replacement fluid.

15. A circuit as in claim 14, wherein said membrane has a pore size of approximately 0.2 micron.

16. A circuit as in claim 14, wherein said fluid circuit is supported in a cartridge that includes a tray shaped element to support said blood, filtrate, and replacement fluid circuit portions.

17. A circuit as in claim 14, wherein said multiple ends include a plurality of bag spikes.

18. A circuit as in claim 17, wherein said fluid circuit is supported in a cartridge that includes a tray shaped element to support said blood, filtrate, and replacement fluid circuit portions.

19. A circuit as in claim 14, further comprising respective pumping portions in said filtrate, blood, and replacement fluid lines that are configured to engage with respective pump actuators to move respective fluids therethrough.

20. A circuit as in claim 19, further comprising a supporting cartridge tray configured to align said pumping portions in respective positions to allow them to engage with pump actuators.

21. A disposable fluid circuit for use in extracorporeal blood treatment systems that supply replacement fluid to a patient, comprising:

a fluid circuit with a blood processing filter and a fluid input connector for receiving treatment fluid;

a filtration set attached to the fluid input connector, the filtration set including a sterilizing filter connected to multiple connector leads that can be connected to respective fluid bags;

there being no flow regulating portions between the connector leads and the sterilizing filter.

22. A circuit as in claim 21, wherein the multiple connector leads are connected to the sterilizing filter by tubing and each of the multiple connector leads is connected by substantially the same length of tubing as others of the connector leads.

23. A circuit as in claim 21, wherein the filtration set has a connector to connect it to the input connector.

24. A circuit as in claim 21, wherein the multiple connector leads are configured to feed into a common line, the sterilizing filter being positioned inline in the common line, and the common line being connected to the fluid input.